These subgroup populations were designed with reference to the clinical trial protocol and previous SHIFT study populations.
The doses of capecitabine, oxaliplatin, and bevacizumab were determined with reference to the TREE1/2 trials [ 33], although the median age of patients enrolled in these studies was 62 years.
The lead investigator in each trial was responsible for determining the clinical significance of any laboratory abnormalities with reference to the relevant clinical trial protocol and standardized laboratory reference ranges, which remained consistent throughout the study period.
With reference to the reporting of randomised controlled trials (RCTs), we recommend using the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement, 9 which was developed to improve the quality of RCT reporting.
With reference to the methodological approach chosen in this trial, it appeared that these patients subjectively perceived the degree of their ADHD-related difficulties as lower than their parents or physicians did.
The pragmatic sample size of 120 participants for the trial was selected with reference to the general rule of thumb recommended by Lancaster et al. [ 27], taking account of the factorial design of this exploratory trial and the primary and secondary outcome measures to be investigated.
Training was accomplished through lectures by P.d.S. and A.S., supplemented by case vignettes and role-play of therapeutic sessions by simulated patients based on case scenarios from the pilot trial, all with reference to the intervention manual.
Occlusal adjustment was performed through trial and error with reference to the distribution of the occlusal force calculated by FE analysis.
This trial has been designed according to the CONsolidated Standards Of Reporting Trials CONSORTT) statement, 12 and is reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement 13 and with reference to the Template for Intervention Description and Replication (TIDieR) checklist.
With reference to the tendency to avoid route 2, as shown in Table 3, in case of no ATIS (first ten trials), a significant difference is shown from trials 1 5 to 6 10.
